FDA 510(k) Application Details - K242063

Device Classification Name Percussor, Powered-Electric

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510(K) Number K242063
Device Name Percussor, Powered-Electric
Applicant Synchrony Medical Ltd.
8 Ariel Sharon
Or Yehuda 6037607 IL
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Contact Anat Shani
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Regulation Number 868.5665

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Classification Product Code BYI
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Date Received 07/15/2024
Decision Date 12/19/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242063


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